Sunday, August 09, 2009

There is Vioxx and Celebrex, I know, I know but I don't know about any other.I just came across with the site CenterWatch "recognized by many of the top media outlets and publications around the world as a leading source of information on the clinical trials industry."I was searching for the 4th phase of clinical trials and this site was at the first page. That's how they explain the 4th phase:

"Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study."

Taken from the market? If anybody knows of a drug that was taken from the market because FDA studied it and came to the conclusion that it's not a good drug please let me know.

According to this same site:

"If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug's long-term effectiveness and its impact on the quality of a person's life."

If anybody knows about any site where I can find FDA real surveillance I would also like to know.

"‘Evergreening’ is the term used to describe the process by which the innovator patents trivial modifications of already-existing drugs which, in turn, extends their monopolies beyond the 20-year period granted for the original patent. It is a common practice in the pharmaceutical industry."

FDA and other countries regulatory agencies seems to be much more concerned in keeping the same drugs at the market. I will never understand how a drug that has killed during clinical trial, Cymbalta, is at the market.Tracy Johnson hanging herself at Eli-Lilly's facilities during Cymbalta clinical trials was not enough or perhaps just an anecdotal evidence and not a scientific data.

Update:*It's still at the market! There is a good article at USA Today about how the Vioxx case:

"Sen. Chuck Grassley, R-Iowa, says the FDA was worse than passive. Investigators for the Senate Finance Committee, which Grassley chairs, met Thursday with FDA researcher David Graham, lead scientist on a study presented in August at a medical meeting in France."

"Graham told the finance committee investigators that the FDA was trying to block publication of his findings, Grassley said in a statement. "Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,' " Grassley said. Graham gave Grassley copies of e-mail that appear to support his claims that his superiors suggested watering down his conclusions."